Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System

NCT05293639 | Completed Results DMC FDA Device

• 1 other identifier: BWI201910
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 30

Brief Summary

To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal atrial fibrillation.

Conditions

Atrial Fibrillation

Keywords

Interventional; Irreversible electroporation; Paroxysmal atrial fibrillation

Outcome Measures

Primary Outcomes (4)

• Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs)

  An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/Cerebrovascular accident (CVA), Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.

  From Day 0 to Day 7 post catheter insertion on Day 0

• Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/CVA, Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.

  From Day 0 to Day 7 post catheter insertion on Day 0

• Pivotal Main Phase Per-Protocol (PP) Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia

  Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial tachycardia \[AT\], or atrial flutter \[AFL\] of unknown origin positive) episodes based on electrocardiographic data (greater than or equal to \[\>=\] 30 seconds on an electrocardiogram \[ECG\], sponsor-provided cardiac event monitor \[CEM\], or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion procedure) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any Direct Current Cardioversion (DCCV) procedure were reported.

  Day 91 to Day 365 post catheter insertion on Day 0

• Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia

  Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin positive) episodes based on electrocardiographic data (\>=30 seconds on an ECG, CEM, or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any DCCV procedure were reported.

  Day 91 to Day 365 post catheter insertion on Day 0

Secondary Outcomes (2)

• Pivotal Main Phase PP Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score

  Baseline, and 12 months post catheter insertion on Day 0

• Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score

  Baseline, and 12 months post catheter insertion on Day 0

Study Arms (1)

Treatment Group

EXPERIMENTAL

PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Device: Pulse Field Ablation

Interventions

Pulse Field Ablation DEVICE

PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation with
• At least two symptomatic AF episodes within last six months from enrollment.
• At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment.
• Failed at least one Class I or Class III antiarrhythmic drug.

You may not qualify if:

• Previously diagnosed with persistent AF (\> 7 days in duration).
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous surgical or catheter ablation for AF.
• Patients known to require ablation outside the PV region
• Documented severe dilatation of the LA (LAD \>50mm) antero-posterior diameter on imaging within 6 months prior to enrollment.
• Documented LA thrombus by imaging within 48 hours of the procedure.
• Documented severely compromised LVEF (\<40%) by imaging within 6 months prior to enrollment
• Uncontrolled heart failure or New York Heart Association Class III or IV
• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran),
• Documented thromboembolic event (including TIA) within the past 12 months
• Previous PCI/MI within the past 2 months
• Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days)
• Valvular cardiac surgical/percutaneous procedure
• Unstable angina within 6 months
• Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (30)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Phoenix Cardiovascular Research

Phoenix, Arizona, 85016, United States

Location

Arrhythmia Research Group (St. Bernards)

Jonesboro, Arkansas, 72401, United States

Location

Cardiovascular Group of Marin/SF Med Group

Larkspur, California, 94904, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Evanston Hospital / Northshore

Evanston, Illinois, 60201, United States

Location

Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55414, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

South Shore University Hospital

Bay Shore, New York, 11706, United States

Location

New York University Langone Med Center

New York, New York, 10016, United States

Location

New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10561, United States

Location

Wakemed Heart and Vascular

Raleigh, North Carolina, 27610, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Baylor Research Institute

Plano, Texas, 75093, United States

Location

Inova Fairfax Medical Center

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth Uninversity

Richmond, Virginia, 23285, United States

Location

Related Publications (2)

• Di Biase L, Reddy VY, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Osorio J, Mansour M, Calkins H, Wazni O, Natale A. Early versus late atrial fibrillation recurrence after pulsed field ablation: insights from the admIRE trial. Europace. 2025 Feb 5;27(2):euaf007. doi: 10.1093/europace/euaf007.

  PMID: 39820338 DERIVED

• Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8;150(15):1174-1186. doi: 10.1161/CIRCULATIONAHA.124.070333. Epub 2024 Sep 11.

  PMID: 39258362 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Irreversible Electroporation Therapy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electroporation Therapies; Therapeutics; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Results Point of Contact

• Title: Reecha Sharma
• Organization: Johnson & Johnson MedTech

rshar120@its.jnj.com

949.789.3919

Study Officials

• Biosense Webster Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: April 18, 2022
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: May 25, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (30)